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Study to Assess the Safety and Tolerability of MBF-015 in Healthy Young Volunteers

NCT06049147 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-09-21

No results posted yet for this study

Summary

This is a single center, randomised, double blind, placebo controlled clinical study to assess the safety and tolerability of MBF-015 in healthy volunteers.This clinical phase I trial is divided in two stages and involves, first, a single ascending dose (SAD) study in healthy young male volunteers and then a multiple ascending dose (MAD) study in healthy young men and woman. MBF-118 is developed for the treatment of multiple sclerosis.

Conditions

  • Safety and Pharmacokinetic

Interventions

DRUG

MBF-015 4 mg oral capsule

MBF-015 oral capsules Histone deacetylase inhibitor

DRUG

MBF-015 16 mg oral capsule

MBF-015 oral capsules Histone deacetylase inhibitor

DRUG

Placebo

Hard gelatin capsules filled with cellulose microcrystalline

Sponsors & Collaborators

  • Medibiofarma S.L.

    lead INDUSTRY

Principal Investigators

  • Martinez · CIM-Sant Pau Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-07
Primary Completion
2023-08-24
Completion
2023-08-24

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06049147 on ClinicalTrials.gov